On May 15, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported it will present preclinical data on the Company’s pipeline of novel therapeutics in three presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, taking place June 22-24, 2020 (Press release, Mirati, MAY 15, 2020, View Source [SID1234558181]). The data to be presented will include preclinical findings on MRTX849, a novel and optimized KRAS G12C inhibitor.

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"We continue to develop an increasing understanding of the role of KRAS in the pathogenesis of cancers as well as the consequences of direct therapeutic inhibition of KRAS. We continue to aspire to apply these learnings toward rational drug development and to make a real and timely impact on patient lives," said James G. Christensen, Ph.D. Executive Vice President and Chief Scientific Officer, Mirati Therapeutics.

Late-Breaking Poster Presentation Details:
Title: The anti-tumor activity of the KRAS G12C inhibitor MRTX849 is augmented by cetuximab in CRC tumor models
Poster Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Presentation Date: June 22, 2020 (available via AACR (Free AACR Whitepaper)’s online platform)
Presenter: Jill Hallin, Principal Scientist, Biology, Mirati Therapeutics
Poster Number: LB-098

Minisymposium Session Details:
Title: Drug-anchored in vitro and in vivo CRISPR screens to identify targetable vulnerabilities and modifiers of response to MRTX849 in KRAS G12C-mutant models
Session Title: Emerging Mechanisms of Resistance to Targeted Therapies
Presentation Date: June 24, 2020 (available via AACR (Free AACR Whitepaper)’s online platform)
Presenter: Lars Engstrom, Principal Scientist, Biology, Mirati Therapeutics
Abstract Number: 5684

Poster Presentation Details:
Title: MRTX2219 is an imidazopyrimidine binder to EED that inhibits polycomb repressive complex 2 (PRC2) and demonstrates robust in vivo activity in EZH2 and SMARCB1-mutant, but not other SWI/SNF-mutant cancer models
Poster Session Title: Epigenetic Targets
Presentation Date: June 22, 2020 (available via AACR (Free AACR Whitepaper)’s online platform)
Presenter: David Briere, Principal Scientist, Biology, Mirati Therapeutics
Poster Number: 1769

About MRTX849

MRTX849 is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly identified, KRAS G12C-positive advanced solid tumors.

On May 15, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that four abstracts have been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, which will take place from June 22 to 24, 2020 (Press release, CRISPR Therapeutics, MAY 15, 2020, View Source [SID1234558180]).

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Session information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website at www.aacr.org.

Title: Functional and single-cell assessment of CRISPR-modified CAR-T cells from NSCLC patients and healthy donors
Session Title: Adoptive Cell Therapy 1
E-Poster Number: 879
Abstract Number: 3338

Title: Allogeneic CAR-T cell products containing 10 gene edits using CRISPR/Cas9 can retain full functionality in vivo and in vitro
Session Title: Adoptive Cell Therapy 1
E-Poster Number: 880
Abstract Number: 4647

Title: Allogeneic anti-PTK7 CAR-T cells for the treatment of solid tumors
Session Title: Adoptive Cell Therapy 3
E-Poster Number: 3243
Abstract Number: 6231

Title: Targeting T cell lymphomas with CRISPR/Cas9-generated anti-CD70 allogeneic CAR-T cells
Session Title: Adoptive Cell Therapy 5
E-Poster Number: 6595
Abstract Number: 3308

On May 15, 2020 Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported preclinical data for its innovative investigational PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer will be presented as an e-poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, to be held from June 22-24, 2020 (Press release, Precigen, MAY 15, 2020, View Source [SID1234558178]). The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and will be accessible on the AACR (Free AACR Whitepaper) e-poster website on June 22, 2020.

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PRGN-3005 utilizes Precigen’s transformative UltraCAR‑T therapeutic platform, which eliminates ex vivo expansion and reduces manufacturing time to allow for rapid next day administration of autologous UltraCAR-T cells following non-viral gene transfer at a medical center’s cGMP facility. PRGN-3005 UltraCAR-T cells simultaneously co-express a CAR specifically targeting MUC16, which is highly expressed on ovarian tumors with limited normal tissue expression; membrane bound IL-15 (mbIL15) for enhanced in vivo expansion and persistence; and a kill switch for improved therapeutic control. Ovarian cancer is the most lethal of gynecologic cancers with high unmet medical need.

"We are pleased to be able to share preclinical data for PRGN-3005 that led to the IND clearance and initiation of the Phase I study," said Helen Sabzevari, PhD, President and CEO of Precigen. "Our preclinical results demonstrate that PRGN-3005 UltraCAR-T administered one day after non-viral gene transfer has superior anti-tumor efficacy and persistence compared to traditional CAR-T cells and represents a promising opportunity for ovarian cancer treatment. We anticipate sharing the first clinical data for PRGN-3005 in the second half of 2020."

Based on these preclinical results, the FDA approved the IND application, and the first-in-human PRGN-3005 Phase I clinical trial for advanced ovarian cancer is currently under way (clinical trial identifier: NCT03907527). The PRGN‑3005 UltraCAR-T clinical study is an open-label, first-in-human Phase I dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3005 UltraCAR-T delivered by intraperitoneal infusion (IP) or intravenous infusion (IV). The study population includes patients with advanced stage (III/IV) recurrent ovarian, fallopian tube, and primary peritoneal cancer who are platinum-resistant and have progressed after receiving standard-of-care therapies or are not eligible to receive available therapies with known clinical benefit.

About Ovarian Cancer
Worldwide, nearly 300,000 women are diagnosed with ovarian cancer every year1 with approximately 22,000 of them in the US2. Since early ovarian cancer is often without obvious symptoms, the disease is frequently diagnosed at an advanced stage where cancer has spread to distant parts of the body, such as the liver or lungs2,3. Five-year survival rates depend on stage and type of ovarian cancer with rates decreasing for advanced stage cancers that have spread to distant parts of the body3.

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

Precigen’s UltraCAR-T Therapeutic Platform
Precigen’s UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements: 1) Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus; 2) Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies; 3) T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and 4) Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, which eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to one day after gene transfer.

Trademarks
Precigen, UltraCAR-T, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

On May 15, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported presentations related to its AUTO1 and AUTO3 programs, the company’s CAR T cell therapies being investigated in Phase 1/2 studies of adult Acute Lymphocytic Leukemia (ALL) and relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL), respectively, at the European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress on June 11 – 14, 2020 (Press release, Autolus, MAY 15, 2020, View Source [SID1234558177]). The AUTO1 data to be presented will expand on the positive data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019 with additional patients as well as longer term data on previously treated patients.

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Oral Presentation Title: ALLCAR19: Updated data using AUTO1, a novel fast-off rate CD 19 CAR in relapsed/refractory B-Acute Lymphoblastic Leukaemia
Session Title: Cellular, antibody and targeted therapy
Abstract: S119
Date/Time: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.
Presenter: Dr. Claire Roddie MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

Oral Presentation Title: Phase 1 Alexander Study of AUTO3 the first Bicistronic Chimeric Antigen Receptor (CAR) targeting CD19 and CD22 with Pembrolizumab in patients with Relapsed/Refractory Diffuse Large B Cell Lymphoma
Session Title: Aggressive Lymphomas: Cellular and bispecific antibody therapies
Abstract: S240
Date/Time: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020
Presenter: Dr Wendy Osborne, MBBS (Hons) MRCP FRCPath, Consultant Haematologist, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Investor call on Monday June 15, 2020
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the EHA (Free EHA Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4838626. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4838626.

On May 15, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended March 31, 2020 on Wednesday, May 20, 2020, before the US markets open (Press release, BioLineRx, MAY 15, 2020, View Source [SID1234558176]).

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The Company will host a conference call on Wednesday, May 20, 2020 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-668-9141 from the U.S. or +972-3-918-0609 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 22, 2020; please dial +1-888-782-4291 from the U.S. or +972-3-925-5928 internationally.